BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAINAGE SET

    MDR report key: 454784 · Received April 21, 2003

    Report

    Report Number
    1820334-2003-00042
    Event Type
    Other
    Date Received
    April 21, 2003
    Date of Event
    March 11, 2003
    Report Date
    March 27, 2003
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SUFFERING FROM PANCREATIC CARCINOMA HAD DEVICE DEPLOYED IN 2003, WITH NO PROBLEMS UNTIL 26 DAYS LATER WHEN NO DRAINAGE OF BILE WAS OBSERVED. X-RAYS WERE TAKEN WHICH SHOWED SEPARATION OF PTCD-NI-A. ALTHOUGH NO PERITONITIS WAS NOTED. A REPEAT OF CATHETER DEPLOYMENT WAS PERFORMED WITH FEVER AND POOR DRAINAGE OF BILE DEVELOPING DURING THE EVENING. PRE-DIC WITH DECREASE OF BLOOD PRESSURE. TREATMENT FOR MOF FACED WITH RESPIRATORY INSUFFICIENCY SYNDROME, IMPAIRMENT OF LIVER AND KIDNEY FUNCTION AS WELL AS BILIARY ATRESIA FROM AUTOIMMUNE PANCREATITIS/PURULENT CHOLANGITIS "OBLITENNEC". PT DIED OF CARDIAC ARREST DUE TO POSSIBLE HYPERKALEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE SET DRAINAGE SET FGE COOK INC NA F1275787

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other